Several Important Meetings Coming Soon — Here’s What I’m Looking At
It looks like the ASCO
floodgates have busted wide open, based on yesterday’s biotech’s wild ride. The
momentum all started last week with Genentech’s
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phase III data on its new anti-angiogenesis drug. The instigator yesterday was
ImClone
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stated it would receive a $6 million milestone payment from its European partner
Merck KGaA related to the upcoming release of phase III data on its new drug
Erbitux in patients with metastatic colorectal cancer. The full data will be
presented at the upcoming ASCO meeting, data eagerly awaited by investors.
ImClone was a big winner yesterday and seems to continue the momentum in the
biotech sector leading up to the ASCO meeting this weekend. Momentum all
started by Genentech last week.Â
Since my May 19 article on the companies with
the most to gain at this meeting, the so-called “Big Four,†ImClone has
performed the best, up 32%. The others, Genentech (up 20%), Millennium
Pharmaceuticals
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have also performed well. I believe there is still much more to come once the
ASCO meeting gets started on Friday.
The FDA
With all the excitement surrounding the influence of the upcoming
cancer meeting on stock prices, one would think the FDA might feel a little left
out. Well, it doesn’t appear that way for long. On Thursday, May 29, the FDA
will show its muscle. The FDA’s Circulatory System Devices Advisory Committee
will make a decision on the pre-market approval application of
Cardima’s
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minimally invasive treatment approach to atrial fibrillation. This company has
developed a catheter system called REVELATION that will allow cardiologists to
treat this common heart arrhythmia with minimally invasive techniques and
potentially avoid major surgery.Â
Atrial fibrillation is commonly treated with
medication, including blood thinners. However, this medication can have
significant side effects and does not work in a number of patients. In those
patients, major open-heart surgery is an option. Surgery is effective in
destroying the abnormal heart tissue responsible for this arrhythmia. However,
the operation is very invasive and carries with it some morbidity and
mortality. Cardima’s technology allows for a minimally invasive approach to
treat patients with atrial fibrillation who do not respond to medication. The
technology is already approved in Canada. Look for this stock to be in play.
In addition, the FDA’s Cardiovascular and Renal Drugs Advisory
Committee will also meet on Thursday to discuss Bayer AG and
GlaxoSmithKline’s
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new drug Levitra for the treatment of erectile dysfunction. Specifically, the
FDA will discuss the cardiac risks potentially associated with the use of this
drug. Levitra is one of the major potential competitors to
Pfizer’s
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ICOS
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will have an immediate impact on all the companies in the erectile dysfunction
space.
After the bell yesterday,
VaxGen
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announced the FDA has given the company the go ahead to start phase I clinical
trials
with its new anthrax vaccine. Remember VaxGen? This company is
developing an AIDS vaccine and released some very soft, highly anticipated, data
from an ongoing clinical study in February. Needless to say, the data was not
well received. The stock price dropped by more than 50% on the bad news and has
never recovered. However, with this announcement the company was rebounding
nicely in after-hours trading and should be in play today. In addition to
VaxGen, other companies developing vaccines for anthrax include Human
Genome
Sciences
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VaxGen appears to have the early lead.
Good
Luck,
Paul
Ruggieri, MD, FACS